Current issues in assuring data integrity in life sciences : 2 Days Seminar

Date

Link to Website

Organizer

WCS Consulting Inc. - NewYorkEventsList http://www.NyEvent

Location

11025,
Vista Sorrento Pkwy

San Diego,

CA,

USA,

ZIP: 92130

Phone:

Current issues in assuring data integrity in life sciences : 2 Days Seminar

Data Integrity is a major concern of regulatory agencies worldwide as evidenced by the increasing number of Warning Letters issued in that area. Some managements have proceeded to implement data integrity programs on the lines of those implemented in “big data”. This has resulted in the escalation of costs and it is disproportionate to the benefits gained. Some even wonder why they continue to receive Warning Letters in spite of spending the dollars to implement programs such as Data Governance etc. etc.

This training focuses on implementing Data Integrity programs using “the least burdensome” approach, a technique that regulators themselves employ to conduct their audits. The training also addresses the evolving concepts and guidance from regulatory agencies such as the recently issued industry guidance on Part 11 for Clinical Investigations among many others.

Addressed will be case studies, inspection approaches, and trends in the issuance of data integrity 483s and warning letters in the recent past. Take back to your work, samples of Data Integrity related directives and SOPs such as Data Integrity Policy, Maintenance of Electronic Records directive and many more that are required to establish a data integrity infrastructure in your company.

This workshop is for novices as well as experienced personnel from QA, IT, manufacturing, regulatory and validation groups. It addresses data integrity issues in all life science industry sectors where data is required to fulfill regulatory requirements. These sectors include medical devices, biologics manufacturing, quality control laboratories, clinical trials, blood establishments, compounding pharmacies etc.

Areas Covered

What is Data integrity

Data Life Cycle design and controls

Elements of a Data Integrity Assurance program

Roles and responsibilities of different groups in ensuring data integrity

Chinmoy RoyBSEE, MSCS US FDA Expert Data integrity & CSV

Chinmoy Roy has 37+ years of experience. He is an internationally recognized subject matter expert in CSV, CFR 21 Part 11, Annex 11, Data Integrity and manufacturing process automation systems. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF, Shimadzu’s annual conference for Asia Pacific, etc.

His expertise stems from his experience in implementing and obtaining “fit for use” certification for over 200 IT systems. He has worked at and consulted with leading US based companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. His pioneering efforts in implementing CFR 21 Part 11 compliant manufacturing IT systems in 1999 while employed by Genentech, was a precursor to FDA’s issuance of Part 11’s Scope and Application guidance in 2003. His workshops are unique in that he blends his field experience to provide case studies to explain the intricacies of implementing regulations. Chinmoy is an Electrical Engineer and a Computer Science post graduate.

NO REFUNDS ALLOWED ON REGISTRATIONS
Prices may go up any time. Service fees included in pricing.
-----------------------------------------------------------------
This event is brought to you by:
WCS Consulting Inc. - NewYorkEventsList
http://www.NyEventsList.com
http://www.BostonEventsList.com
http://www.SFBayEventsList.com
-----------------------------------------------------------------